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OpenTrials
Completed

NCT Number: NCT02429648

Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation

The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Ablation of persistent/permanent Atrial Fibrillation (AF) remains a challenge. There are several strategies to improve the outcomes of persistent/permanent AF ablation. At the Cleveland Clinic one of the commonly used strategies is Direct Current Cardioversion (DCC). Depending on physician preference, patients may be ablated in atrial fibrillation then Direct current cardioverted; or Direct current cardioverted and ablated in sinus rhythm. Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice.

The purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent Atrial Fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent or long standing persistent AF resistant to anti-arrhythmic medication. Must have been present for more than 2 months
  • Therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or TEE performed prior to the procedure
  • Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control
  • Scheduled for Pulmonary Vein Isolation
  • Amiodarone will be stopped at least 3 months prior to procedure

Exclusion criteria

  • Reversible causes of AF such as pericarditis, hyperthyroidism
  • Presently with Valvular Heart disease requiring surgical intervention
  • Presently with coronary artery disease requiring surgical intervention
  • Early Post-operative AF (within three months of surgery)
  • Previous MAZE or left atrial instrumentation
  • Life expectancy <= 2 years
  • Social factors that would preclude follow up or make compliance difficult.
  • Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
  • Enrollment in another investigational drug or device study
  • Patients with severe pulmonary disease
  • Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction

Treatment and study plan

DCC first then PVI

Procedure

DCC performed prior to PVI

PVI then DCC after

Procedure

DCC performed after PVI, if patient remains in Atrial Fibrillation

Primary outcomes

  1. Duration of procedure

    Time frame: day of procedure

Secondary outcomes

  1. Composite of duration of fluoroscopy, and radiation exposure doses

    Time frame: day of procedure

  2. Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG

    Time frame: 12 months

  3. frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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